Device Classification Name |
catheter, intravascular, therapeutic, long-term greater than 30 days
|
510(k) Number |
K172885 |
Device Name |
HydroPICC |
Applicant |
Access Vascular, Inc |
175 Middlesex Turnpike |
Bedford,
MA
01730
|
|
Applicant Contact |
Elizabeth Kinnal |
Correspondent |
Access Vascular, Inc |
175 Middlesex Turnpike |
Bedford,
MA
01730
|
|
Correspondent Contact |
Elizabeth Kinnal |
Regulation Number | 880.5970
|
Classification Product Code |
|
Date Received | 09/21/2017 |
Decision Date | 02/20/2018 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|